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Not yet recruitingNCT07572604CAREPATHUpdated Aug 18, 2026

Community Health Worker Assessment for Postpartum Health

An interventional study of CAREPATH and Standard of Care in Postpartum Complication and Health Care Seeking Behavior, sponsored by University of Arkansas. Not yet recruiting. Open to female participants aged 16 Years to 44 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-18.

Sponsored by University of Arkansas · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
500
Allocation
Randomized
Ages
16 Years to 44 Years
Sex
Female
01

Study summary

The goal of this randomized controlled trial is to compare the CAREPATH intervention with standard of care on postpartum outcomes among up to 500 postpartum individuals. The CAREPATH includes 3 postpartum telehealth visits from a perinatal CHW.

The study will address the following aims:

Aim 1: Compare: A) CARE PATH and B) standard of care among postpartum individuals on:

Aim 1.A: postpartum visit completion.

  • Hypothesis 1.A: Patients assigned to the CARE PATH will have higher completion of their postpartum visit compared to those receiving standard of care.

Aim 1.B: early detection of postpartum complications.

  • Hypothesis 1.B: Patients assigned to the CARE PATH will be more likely to experience early detection of postpartum complications that arise compared to those receiving standard of care.

Aim 1.C: hospital readmission and ED visits postpartum.

  • Hypothesis 1.C: Patients assigned to the CARE PATH will be less likely to have hospital readmission or an ED visit compared to those receiving standard of care.

Aim 2: Explore the impact of A) CARE PATH and B) standard of care on reproductive life planning/contraceptive counseling.

  • Hypothesis 2: Patients assigned to the CARE PATH will be more likely to report reproductive life planning/contraceptive counseling.
02

Conditions studied

  • Postpartum Complication
  • Health Care Seeking Behavior

Keywords

  • Postpartum visit
  • Postpartum care
  • Postpartum complications
03

Who can participate

Ages eligible
16 Years to 44 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Age 16-44 years old
  • ≤ 38 weeks pregnant
  • Ability to speak English, Spanish or Marshallese

Exclusion criteria

Exclusion Criteria:

  • Type 1 diabetes on an insulin pump followed closely by endocrinology
  • Uncontrolled Type 2 diabetes
  • End stage renal disease followed closely by nephrology
  • ICU admission at any point during pregnancy or delivery hospitalization
  • Other maternal conditions requiring additional surgeries (i.e. cesarean hysterectomy or intrapartum or postpartum oophorectomy/appendectomy)
  • Incarceration
  • Mental disability limiting decision-making capacity
  • Uncontrolled chronic hypertension
  • HELLP syndrome during pregnancy
  • Sickle cell disease
  • Maternal heart condition or heart disease
  • Opioid use disorder
  • Lupus
  • Thrombophilia or blood clots
  • Other maternal conditions or complications, known during pregnancy or delivery hospitalization, requiring prolonged hospitalization postpartum
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
500 participants (estimated)

Study arms

  • Experimental
    CAREPATH

    Participants in the CAREPATH arm will receive standard of care plus three telehealth visits from a perinatal community health worker during the first six weeks of the postpartum period. During the visits, participants will be screened for postpartum complications using a symptom monitoring checklist that covers urgent maternal warning signs, as well as anxiety and depression.

    Behavioral: CAREPATH

  • Active comparator
    Standard of Care (SoC)

    Participants in the SoC arm will receive education on symptoms of postpartum complications and assistance scheduling their postpartum visit with their healthcare provider.

    Other: Standard of Care

Interventions

  • BehavioralCAREPATH

    Patients will received standard of care plus three telehealth visits with a perinatal community health worker.

  • OtherStandard of Care

    Patients will receive standard of care which includes: education on postpartum complications symptoms and when to call their healthcare provider, assistance scheduling their postpartum visit, and any healthcare deemed necessary by providers.

05

What researchers measure

Primary outcomes

  1. Postpartum visit completion

    Binary measure (yes/no) of visit completion

    Time frame: 6 weeks postpartum

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT07572604
Lead sponsor
University of Arkansas
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Responsible party
Sponsor
First posted
May 7, 2026
Start date
Oct 31, 2026 (estimated)
Primary completion
Aug 31, 2029 (estimated)
Completion
Aug 31, 2029 (estimated)
Last update
Aug 18, 2026

Study contacts

Brett Rowland, MA
Contact
mbrowland@uams.edu
4797138661
Kenny Halloran
Contact
khalloran@uams.edu
4797138661
Pearl McElfish, PhD
principal investigator · University of Arkansas

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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